贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.892992772993732998602992622995792994700.09
29.932993992995922994960.05
单位质量响应值RSD%判断
30280.0830160.730.28数据可信
供试品溶液-24081401批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12187-21871.4431.306.711.441.306.71
21777-17771.1731.17
31951-19511.2881.29
41947-19471.2851.28
51950-19501.2871.29
62016-20161.3301.33
15min13274-32742.1612.172.092.182.192.14
23183-31832.1012.11
33376-33762.2282.24
43354-33542.2132.23
53269-32692.1572.17
63298-32982.1772.19
20min14066-40662.6832.622.302.722.662.27
23909-39092.5802.62
33930-39302.5942.63
43861-38612.5482.59
53926-39262.5912.63
64087-40872.6972.74
30min14585-45853.0262.991.473.103.061.52
24582-45823.0243.09
34480-44802.9573.02
44477-44772.9553.02
54452-44522.9383.01
64601-46013.0363.11
45min14970-49703.2803.344.723.383.434.53
25176-51763.4163.51
34837-48373.1923.29
45477-54773.6153.71
54985-49853.2903.39
64879-48793.2203.32
60min14908-49083.2393.373.123.383.513.00
25179-51793.4183.55
35082-50823.3543.49
45376-53763.5483.69
55018-50183.3123.45
65077-50773.3513.49
极限15333-53333.5203.471.783.703.641.67
25341-53413.5253.70
35190-51903.4253.60
45154-51543.4013.58
55158-51583.4043.58
65331-53313.5183.69
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.892997482997122997482997172997132997280.01
29.932986692986822986760.01
单位质量响应值RSD%判断
30306.1730078.150.54数据可信
供试品溶液-24081401批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12796-27961.8470.7889.591.850.7889.62
2-0.0000.00
31413-14130.9330.93
4-0.0000.00
51614-16141.0661.07
61299-12990.8580.86
10min14578-45783.0243.005.293.043.005.48
24461-44612.9472.95
34827-48273.1893.20
44110-41102.7152.71
54620-46203.0523.06
64615-46153.0493.06
15min16666-66664.4034.292.134.464.342.24
26517-65174.3054.34
36641-66414.3874.43
46374-63744.2114.24
56486-64864.2854.33
66320-63204.1754.22
20min17808-78085.1585.167.015.265.256.82
27428-74284.9074.99
37652-76525.0555.15
48901-89015.8805.96
57577-75775.0055.10
67519-75194.9675.06
30min18410-84105.5555.622.415.725.772.31
28601-86015.6825.82
38877-88775.8646.01
48434-84345.5715.71
58298-82985.4815.63
68437-84375.5735.72
45min19143-91436.0406.131.466.266.341.45
29076-90765.9956.19
39329-93296.1636.38
49388-93886.2026.41
59313-93136.1526.36
69406-94066.2136.42
60min19530-95306.2956.568.026.586.847.72
29686-96866.3986.66
39641-96416.3696.65
49493-94936.2716.54
59716-97166.4186.70
611552-115527.6317.91
极限19559-95596.3146.321.096.676.681.16
29383-93836.1986.53
39584-95846.3316.69
49608-96086.3476.69
59622-96226.3566.71
69688-96886.4006.76
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.892993932994262992232994332994712993890.04
29.932996032997462996740.04
单位质量响应值RSD%判断
30271.8930178.650.22数据可信
供试品溶液-24081401批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118437-1843712.16612.1711.4812.1712.1711.47
219767-1976713.04313.04
317454-1745411.51711.52
420246-2024613.35913.36
514711-147119.7079.71
620020-2002013.21013.21
10min151708-5170834.11936.323.9134.2536.453.91
253541-5354135.32935.47
356063-5606336.99337.12
457144-5714437.70637.85
554685-5468536.08436.19
657076-5707637.66137.81
15min171467-7146747.15749.262.4847.6749.802.48
275952-7595250.11750.65
373443-7344348.46149.00
475676-7567649.93550.50
575229-7522949.64050.15
676177-7617750.26550.83
20min184780-8478055.94257.672.2356.9858.752.22
288731-8873158.54959.64
385123-8512356.16857.25
488949-8894958.69359.81
588995-8899558.72359.78
687785-8778557.92559.05
30min1101795-10179567.16968.782.0868.8370.502.07
2104890-10489069.21170.96
3103020-10302067.97769.68
4107592-10759270.99472.77
5105506-10550669.61871.33
6102586-10258667.69169.46
45min1116445-11644576.83678.062.3279.2480.562.30
2118267-11826778.03880.55
3116590-11659076.93279.39
4123584-12358481.54784.11
5118450-11845078.15980.65
6116499-11649976.87179.39
60min1125008-12500882.48682.732.0185.7586.081.97
2124731-12473182.30385.68
3126476-12647683.45586.77
4129660-12966085.55689.02
5124123-12412381.90285.26
6122228-12222880.65284.03
极限1135817-13581789.61889.141.2493.7993.421.22
2136623-13662390.15094.45
3135307-13530789.28293.52
4136629-13662990.15494.57
5133747-13374788.25392.52
6132456-13245687.40191.67
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